FDA 101 Curriculum

Part of FDA’s transparency initiative is to better explain to the public what the agency does, in a useful, and user-friendly format. The task force would like your help in coming up with a list of questions about the FDA that you would like answers to. For example, possible questions can include: What products does FDA regulate? How do you find out if a medicine is approved by FDA? Your suggestions will be used by the task force to develop a FDA 101 curriculum for consideration by Commissioner Hamburg.

Our question is:

What questions and topics should be included in a FDA 101 curriculum? How should the agency present that information?

FDA should place the MedWatch 3500A forms on line concerning drugs and allow the public to access the reports. The medical device side is far more technologically advanced and consumers can easily find out about adverse events concerning medical devices. On the drug side of FDA, the database is outdated and nearly impossible to search or read. This is unacceptable because the public has a right to know about the adverse events caused by the drugs approved and monitored by FDA. This critical information is being denied to patients and it could save people from serious long term side effects. It also gives patients more information to make more informed decisions.

I agree with John Mack that the FDA website is almost impossible to search effectively. The public cannot benefit from increased transparency if the FDA website is so unwieldy. Many searches result in being directed from link to link to link with no end in sight. Other searches yield nothing. A perfect example: I searched the name of a company I KNOW has interacted with FDA on a new medical device (rec’d 501K exempt status), nothing. Filled in ALL the boxes on CDRH’s search page, nothing. Omitted everything from the search boxes except the “Owner/Operator Number” , bingo, there it was. Arggghhh.

The FDA should explain what documents are necessary to support clinical trial data. Right now, FDA talks about “adequate and accurate subject case histories” and not much else. There should be a comprehensive index of essential documents as there is in the International Conference on Harmonization E6 document (Good Clinical Practice). An example would be what correspondence is it necessary to keep? E6 tells us. FDA does not.
People conducting clinical trials are often confused by what FDA requires. As a result, we have “regulation by rumor.” Clear, constructive guidance would be very helpful. ICH is at:http://www.ich.org/LOB/media/MEDIA482.pdf

I have to say that it is really hard to find your blog. Honestly, I came across it by accident, and don’t even know how I got here. But, if you are wanting to educate the public, I suggest that you make it easier to find and access your blog.

I believe this to be a step in the right direction,but as a consumer of drugs i have learned the hard way,of the issues you face.There really has to be one answer,there must be fire walls in place between the FDA and the pharmaceutical companies,people or companies who can potencially profit from FDA decisions on drugs,must not be part of the discussion.Clinical trials,not paid for by those who will benefit.Full and absolute disclosure,the good and the bad,are an absolute must.The task is daunting but neccasary,for the FDA to gain back its reputation as protector of the public.

What do I need to know about food allergies?
FDA has already partially answered this question in its educational material titled “Food Allergies: What You Need to Know” available at http://www.fda.gov/Food/ResourcesForYou/Consumers/ucm079311.htm .
However, the “About Other Allergens” section, where FDA advises consumers to “read the food label’s ingredient list carefully to avoid the food allergens in question” is both disingenuous and dangerously misleading.
FDA is well aware that consumers with allergies not covered under the FALCPA do “not receive sufficient information from food labels to protect their safety”.
(Reference: Laura E. Derr, When Food is Poison: the History, Consequences, and Limitations of the Food Allergen Labeling and Consumer Protection Act of 2004, 61 FOOD & DRUG L.J. 65, 109 (2006).)
When my daughter was first diagnosed with a life-threatening allergy to sesame, I was not concerned about FDA’s ability to protect the public health. I would now classify myself as a critic of the agency. I would like to regain trust and confidence in the FDA, but that trust has to be earned. How can I trust FDA when I know that, although understanding the labeling loopholes that still exist for many allergens, FDA did not explain the risks to the public?
Please don’t sugarcoat the information – explain the intricacies of labeling (ex. – flavors, spices, additives, sources of ingredients, genetically modified food, limited focus on containing cross-contamination for allergens not covered under the FALCPA). Lives may depend on consumers understanding this information.
In addition, the following quote is outdated: “the law identifies the eight most common allergenic foods” as sesame is now considered by the scientific community to be among the top eight food allergens in the U.S.
(Reference: “Sesame Allergies on the Rise in U.S.: Sesame Seed Allergy Now Among Most Common Food Allergies” by Charlene Laino available at http://www.webmd.com/allergies/news/20090316/sesame-allergies-on-the-rise-in-us ).

FDA – used to – have one of the most transparent government sites in the world. I agree with the comment that it is impossible to search, so just use Google advanced search and limit searches to site:fda.gov and the results are different and much better. I personally dont bother with the site search function on fda.gov anymore.
Almost all the questions asked on here so far can be answered on the site, and many organizations and universities provide courses and materials that tell people where to find the answers. A consumer should not be expected to spend $500 for a day course or $5,000 for a semester but any industry or investor that wont invest in that, frankly, is just not interested in finding the real answer. (Perhaps some keep looking because they want the answer that they WANT, not the right answer.) If they want the latest scientific requirements they need to hire staff to know that, and not count on FDA to know it for them. FDA will never be able to be as current as every single manufacturer on every product, so each company has an obligation to stay on top of its own products. That’s they way the law is writen and the way the core function of FDA is designed. The costs of research and approval are on the applicant, not the government.
The OLD CDRH website leading interested persons through its site and the regulatory process for devices was wonderful, but in the web redesign, instead of making the other Centers provide that, under the banner of uniformity, Device Advice is buried and much harder to navigate now. Bring it back. Make all the Centers follow it.
Until FDA is fully staffed, investing in transparency diverts the little staff there is from appprovals and compliance.
In sum, at least since its response to the AIDS crisis, FDA has been transparent to professionals and organizations who need to know and who make the effort to learn. However, the new website does not improve transparency but makes it worse.

Not only is transparency needed. There needs to be a simple, yet detailed way for the “red tape” to be in place. With the different phases and backlog for FDA approval, its truly not remarkable that there is so much confusion.

The OLD CDRH website leading interested persons through its site and the regulatory process for devices was wonderful, but in the web redesign, instead of making the other Centers provide that, under the banner of uniformity, Device Advice is buried and much harder to navigate now. Bring it back. Make all the Centers follow it.
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i like it. “FDA should place the MedWatch 3500A forms on line concerning drugs and allow the public to access the reports. The medical device side is far more technologically advanced and consumers can easily find out about adverse events concerning medical devices. On the drug side of FDA, the database is outdated and nearly impossible to search or read. This is unacceptable because the public has a right to know about the adverse events caused by the drugs approved and monitored by FDA. Schools at http://www.joingame.net This critical information is being denied to patients and it could save people from serious long term side effects. It also gives patients more information to make more informed decisions.” nice post. thank you.

I agree with Carl I came across this site a few days ago doing a Google search then I thought I would comment at a later time. well I left the page thinking I could come back to it again, it took me about 2 days to find the page again. You need to make information standard and easy to find and easy to navigate doing searches on the FDA Web site is almost a joke. No disrespect given here but most people can barely turn on a computer much less know how to use search syntax and complex searches.

The website needs to be user friendly with different layers enabling people with minimal skills to get basic information yet allow others to drill deep for more detailed knowledge. In the past I have found the information I needed but it took some time and skill in the search process.

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